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Santhera Provides Update on Filing for Conditional Marketing Authorization in Europe for Puldysa® (Idebenone) in Duchenne Muscular Dystrophy
Santhera Pharmaceuticals announces its intention to file an application for Conditional Marketing Authorization (CMA) for Puldysa® (idebenone) for the treatment of respiratory dysfunction in Duchenne muscular dystrophy (DMD) with the European Medicines Agency (EMA). Following scientific advice from EU regulatory authorities, completion and filing of the CMA for Puldysa in DMD is planned for the second quarter of 2019.
Santhera has expanded and substantiated its previous regulatory dossier with additional clinical data from patients treated with idebenone, new analyses of previously submitted data and new comprehensive natural history data, addressing requests from regulatory authorities. In its entirety, these new data demonstrate clinically relevant patient benefits and sustained therapeutic efficacy during treatment with idebenone for up to six years in patients with DMD. The new data package and filing strategy have been discussed in several pre-submission meetings with national regulatory authorities.
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